Journal of Endovascular Therapy最新文献

Purpose: To present endovascular management of an intraoperative type IIIc endoleak (EL) in a patient with migration of the right renal artery (RRA) bridging stent graft (BSG) during branched aortic aneurysm repair.

Technique: The technique is demonstrated in an 80-year-old woman who underwent branched endograft repair of a symptomatic 6-cm type II TAAA. The t-Branch thoracoabdominal stent graft was positioned without difficulty. A "partial graft deployment" was performed, with the distal portion of the device remaining inside the delivery system and the right renal and superior mesenteric arteries were stented. When the constraining wires were removed, the RRA BSG migration from the branch was displayed, due to endograft twisting resulting in a horizontal rotation of the t-Branch. The RRA BSG remained oriented upward with the proximal edge positioned above the distal edge of the directional branch, making cannulation very difficult. This bailout technique uses a balloon placed at the level of the RRA BSG through the celiac artery (CA) directional branch; keeping the balloon inflated and in thrust, the edge of the BSG has moved downward making it possible to engage it and relining through the RRA directional branch.

Conclusions: This paper describes an endovascular bailout technique for relining a displaced bridging stent graft, oriented upwards with the proximal edge positioned above the distal edge of the directional branch.Clinical ImpactThis sophisticated technique adds to the spectrum of bailout techniques that can be applied in cases of type IIIa EL with migration and complete separation of BSG.

Objective: The objective of this study was to compare the perioperative performance of the novel large-diameter composite polycarbonate polyurethane graft and the polyester graft.

Methods: In this study, we retrospectively analyzed 14 patients with thoracic aortic prosthesis replacement from 2016 to 2021. The preoperative, intraoperative, and postoperative data of the 2 groups were assessed in detail.

Results: We defined the patients with polyester grafts as the control group and the patients with polycarbonate polyurethane grafts as the experimental group. The total operation time of the experimental group was significantly shorter than that of the control group, which were 159.29±38.13 minutes and 252.57±64.40 minutes, respectively (p<0.001). The length of time from aortic opening to the end of operation in the experimental group was significantly shorter than that in the control group, which were 70.43±8.08 minutes and 124.71±37.59 minutes, respectively (p<0.001). The mean total drainage of pleural fluid was lower in the experimental group than in the control group (383.43±139.68 mL vs. 828.00±457.27 mL; p<0.05). The mean postoperative in-hospital time was shorter in the experimental group than in the control group (6.71±0.75 days vs. 9.43±2.82 days; p<0.05).

Conclusions: This study provides preliminary evidence that the novel artificial blood vessel has good mechanical properties, histocompatibility, hemocompatibility, and anti-seepage function in the human body. A multicenter randomized controlled trial is needed for further validation.Clinical ImpactThe novel hybrid polycarbonate polyurethane (PCU)/polyester three-layered large-diameter artificial blood vessel simulates the internal, middle, and external layers of the human blood vessels. The inner and outer layer are made of PCU, and the middle reinforcing layer is woven by polyester. Because of the three-layered structure, this artificial blood vessel has excellent anti-seepage and anti-infection functions. the inner and outer layers of the blood vessel made of PCU let this artificial blood vessel has excellent blood compatibility, outstanding biocompatibility, high endothelialization rate, and 100% patency. By comparing the perioperative outcomes with the polyester artificial blood vessel, we find it has good mechanical properties, histocompatibility, hemocompatibility and anti-seepage function in the human body.

Introduction: To confirm real-world clinical practice results reported with anatomically fixed bifurcated endograft, a physician-initiated study was designed-AFX2-LIVE registry.

Materials and methods: From November 2019 to August 2021, investigators enrolled all consecutive patients treated with AFX2 (Endologix Inc., Irvine, CA, USA) endograft. Patients with abdominal aortic aneurysms (AAAs), penetrating aortic ulcers (PAU), and isolated infrarenal aortic dissections were included. Clinical and anatomical data, including baseline, intraoperative, and in-hospital details, as well as follow-up data, were collected in an anonymized prospectively compiled database. The primary endpoint of this study was to evaluate the technical and clinical success of endovascular aortic repair (EVAR) using AFX2 endograft.

Results: A total of 535 patients were enrolled from 43 Italian and Spanish centers and analyzed according to the protocol. Four hundred eighty-nine patients were male (91.4%), with a mean age of 75±8.92 years (range 52-94). Four hundred sixty-six patients (87.1%) were treated for AAA, 49 (9.3%) for PAU, and 20 (3.6%) for isolated abdominal aortic dissection. A proximal extension was needed in 48% of the cases. Assisted technical success was achieved in all but one patient (99.8%). At 30 days follow-up, no AAA-related deaths were recorded, and nine patients (1.6%) required reintervention. At a mean follow-up period of 15.22±13.65 (range 1-53) months, data were available for 479 patients (89.5%). Clinical success was achieved in 98.2% (95% confidence interval [CI]: 96.4-99.1) at 3 months, 93.9% (95% CI: 90.1-96.1) at 1 year, and 74.1% (95% CI: 62.8-82.4) at 4 years follow-up. The estimated freedom from all-cause mortality was 97.7%, 93.4%, 81.6%, 77.5%, and 70.9%, and freedom from AAA-related mortality was 100%, 99.6%, 99.6%, 99.6%, and 97.3% at 3, 12, 24, 36, and 48 months, respectively. Twenty reinterventions (3.7%) were required in 19 patients, of which 3 late open conversions (0.6%) were performed, and 2 AAA-related deaths were observed.

Conclusion: This study demonstrated excellent clinical and technical success rates of EVAR with anatomically fixed endografts, providing valuable insights into real-world clinical outcomes.Clinical ImpactThe AFX2-LIVE study could have a significant impact by providing robust evidence supporting the effectiveness and safety of EVAR using bifurcated endografts with anatomical fixation in real-world clinical practice, ultimately leading to improved outcomes and enhanced patient care in the management of abdominal aortic pathologies.

Purpose: This study aims to assess the safety and efficacy of the fenestrated Anaconda device for the treatment of complex aortic aneurysms over 1 year in daily clinical practice.

Materials and methods: All patients who received the graft between October 2019 and October 2020 were prospectively enrolled in an observational, multicenter national registry. The primary endpoint was the aneurysm-related 1-year mortality rate. Secondary endpoints included all-cause mortality, technical success, device-related adverse events (AEs) and major complications, secondary reinterventions, endoleaks, target vessel (TV) outcomes, and a center-volume analysis comparing mortality and secondary reintervention rate between expert centers (>15 F/BEVAR per year) and nonexpert centers (≤15 F/BEVAR per year).

Results: Ninety-seven patients from 28 centers were treated. Aneurysms types included juxta-renal and short neck (84.6%), pararenal (5.2%), paravisceral (3.1%), and type IV thoracoabdominal (2.5%). Configurations with 1, 2, 3, and 4 fenestrations were used in 2, 12, 18, and 65 cases, respectively, totaling 350 TVs. Technical success was 98.0%, with 1 type Ic and 1 type IIIc endoleak. Mean follow-up was 468 days. Ten patients died, with 8 deaths (8.2%) due to non-aortic causes and 2 deaths (2.1%) from unknown causes. The estimated 1-year survival rate was 92.7% (95% CI: 87.8-98.1%). The reintervention rate at 30 days was 11.3% and the estimated reintervention rate at 1 year was 21.6% (95% CI: 12.7-29.6%). No type Ia endoleak occurred during follow-up. Three type III endoleaks occurred and required reintervention. Three TV occlusion occurred, yielding a 1-year TVI-free rate of 92.4% (95% CI: 89.4-99.3). No device-related major complication was recorded, and 3 device-related AEs occurred: 1 limb migration, 1 limb kinking and 1 limb thrombosis. There was no statistically significant difference in mortality and survival without reintervention between expert and nonexpert centers (Log rank p=0.52 and p=0.16, respectively).

Conclusion: The fenestrated Anaconda device demonstrated acceptable early and at 1-year safety and efficacy for treating primarily juxta-renal and short-neck aortic aneurysms, in centers with varying levels of experience.Clinical ImpactThe Anaconda Fenestrated, as the second commercially available custom-made device for complex endovascular aortic surgery, might adress some anatomical challenges. Following market authorization, this registry presents the 1-year outcomes of real-world device usage in a large number of centers, including small clinics. The results indicate that the device provided adequate efficacy and safety for treating mostly juxta-renal and short neck aneurysms, with notable improvement in technical success rate compared to older reports.

Introduction: Left subclavian artery (LSA) preservation during thoracic endovascular aortic repair (TEVAR) has been related to low morbidity. This study investigated the incidence of LSA stent compression in patients managed with fenestrated endovascular arch repair (f-Arch) and evaluated the impact of anatomic and technical factors on LSA stent outcomes.

Methods: A single-center retrospective analysis of patients managed with single-fenestration devices (Cook Medical, Bloomington, IN, USA) for LSA preservation, between January 1, 2012 and November 30, 2023, was conducted. Anatomic (arch type, bovine arch, distance between the LSA and most proximal bone structure, left common carotid artery and aortic lesion, take-off angle, diameter, thrombus, calcification, dissection, tortuosity) and technical parameters (stent type, diameter, length, relining, post-dilation) were evaluated. Stent compression was any ≥50% stenosis (using center luminal line) of the stent compared with its initial diameter. Clinical outcomes included stroke and upper limb ischemia at 30 days and follow-up. Technical outcomes included stent compression and need for reintervention.

Results: Fifty-four cases were included. Only balloon-expandable covered stents were used, and relining during the index procedure was performed in 18%. No stroke or arm ischemia was recorded. One stent compression was detected at 30 days. During follow-up, no stroke or arm ischemia was diagnosed. Nine cases (18%) presented stent compression, with a mean time of stent-compression diagnosis at 18 months (interquartile range [IQR]=37, range=1-58 months) after the index procedure. Five (56%) underwent secondary relining. Follow-up after reintervention was uneventful. Lower distance to the nearest bone structure (compression group [CG]: 11.7±8.9 mm vs non-compression group [NCG]: 23.0±7.8 mm, p=0.003) and higher tortuosity index (CG: 1.3±0.4 vs NCG: 1.2±0.1, p=0.03) were associated with LSA stent compression.

Conclusion: LSA stent compression in patients managed with f-Arch affected 1 in 5 cases, without clinical consequences. Distance to the nearest bone structure and higher tortuosity were associated with LSA stent compression.Clinical ImpactFenestrated endovascular arch repair for the preservation of the left subclavian artery (LSA) in patients needing landing within the aortic arch has been performed with encouraging outcomes. This analysis showed that LSA stent compression is met in 18% of patients, without though any clinical consequence. Pre-operative anatomic parameters, as lower distance to the nearest bone structure and higher tortuosity index affect negatively LSA stent performance while stent parameters seem to have no impact.

Objectives: The aim of the study was to investigate the safety and feasibility of branched endovascular arch repair (b-TEVAR) with a custom-made double or triple inner branched arch endograft using a short dilator tip (35 mm) in patients with aortic arch pathologies.

Methods: Retrospective analysis of all consecutive patients undergoing b-TEVAR with a short dilator tip for the treatment of aortic arch pathologies in a high-volume tertiary center between January 2019 and July 2023. The combined primary endpoint was technical success and perioperative complications caused by the endograft, including tip-induced cardiac injury and trackability issues. Secondary endpoints were major adverse events (MAE), including morbidity, mortality, and reinterventions within 30 days.

Results: During a 4-year period, 22 patients (median age 72 years, 16 males) were treated with a custom-made double or triple inner-branched TEVAR for different aortic arch pathologies using a short dilator tip (35 mm). After initial exclusive treatment of patients with previous valve replacement, the use of a short dilator tip became standard. Eighteen patients received a triple- and 4 patients received a double-branched endograft. Seventeen patients (77.3%) underwent elective treatment, while 5 patients underwent urgent repair due to contained rupture or symptomatic aneurysms. The technical success was 100%. No tip-induced cardiac mortality and morbidity occurred perioperatively. The trackability of the device was in no case affected by the short tip. Within 30 days, the MAE rate was 45%, including one death. No re-intervention had to be performed.

Conclusion: Endovascular aortic arch repair with inner-branched arch endografts using a short dilator tip (35 mm) appears to be safe and technically feasible and could potentially reduce the risk of fatal myocardial injuries.Clinical impactDue to safe and stable maneuverability and deployment of endograft in zone 0 the use of short dilator tip might have the potential to become standard in endovascular branched arch repair. This is one of the first reports on the use of short dilator tip and associated complications in endovascular branched arch repair.

Objective: To understand possible reasons for poor durability of the Nellix (Endologix Inc., Irvine, USA) endovascular aneurysm sealing (EVAS) device.

Materials and methods: 21 Nellix endoprostheses explanted for endoleaks and migration underwent visual examinations of stent structures and instrumental examinations of the polymer endobags on 4 devices. We harvested 2.0-gram polymer slices out of each of them and tested the samples in an in vitro implantation replication that included wet and dry exposures. During the wet phase, we placed samples in a beaker with saline, mimicking the filling of the endobags during implantation. An exposure to a 37°C environment with 60% humidity during the dry phase replicated the postimplantation conditions inside the aneurysmal sac.

Results: Iatrogenic defects affected 16 (76%) metal stents and 20 (95%) endobags. The polymer was disintegrated owing to degradation in 15 (71%) cases. The polymer could lose more than 70% of its initial weight when partially dehydrated and regain 80% when placed in saline. We observed volume decrease and polymer fragmentation during these study phases.

Conclusions: The polymer can lose weight and volume while it dehydrates. This structural degradation of the polymer could lead to the development of endoleaks and/or migration of the device.Clinical ImpactBased on the results of previous investigations, due to possible endovascular device degradation, patients with endografts should be offered life-long surveillance, and the Nellix device is no exception. Herein we suggest polymer degradation as one of the possible reasons for the device failure. Although Nellix has been withdrawn from the market, there are numerous patients with this type of endograft. Due to its unpredictable performance in the medium and long term, these patients should be recommended enhanced life-long surveillance every 6 months. Any suspicious conditions during the follow-up must be taken seriously and explantation should be considered.

Background: This study aims to assess the effectiveness and identify the risk factors associated with postoperative restenosis in patients with femoropopliteal in-stent restenosis (FP-ISR) disease treated with excimer laser ablation (ELA) combined with drug-coated balloon (DCB) versus DCB alone.

Methods: This retrospective real-world study compares patients with FP-ISR treated with ELA + DCB versus DCB alone. Additionally, subgroup analysis was conducted for long-segment lesions (lesion length ≥200 mm) and Tosaka III lesions. Then Cox regression analysis was used to examine 24-month outcomes of target lesion revascularization and restenosis.

Results: We found no significant differences in primary patency and freedom from clinically driven target lesion revascularization (CD-TLR) at 24 months between the ELA + DCB group (49 patients) and the DCB group (82 patients). In the subgroup analysis of long-segment lesions (target lesion length ≥200 mm), the results showed that ELA + DCB was superior to DCB at 24 months in terms of both primary patency (55.0% vs 35.3%; P = 0.048) and freedom from CD-TLR (77.8% vs 50.8%; P = 0.033). The 2 treatment methods did not show statistical significance in the subgroup analysis of Tosaka III patients. Target lesion length of ≥200 mm was found to have a significant association with restenosis (hazard ratio = 5.28; 95% CI, 2.48-11.23; P < 0.001) and freedom from CD-TLR (hazard ratio = 3.02; 95% CI, 1.02-9.30; P = 0.044) in the multivariate analysis.

Conclusions: We do not have sufficient evidence to show a significant difference between ELA + DCB and DCB alone for FP-ISR. However, for patients with long-segment FP-ISR lesions, ELA + DCB may provide better long-term patency.Clinical ImpactOur results suggest that for patients with long-segment (≥200 mm) FP-ISR, the efficacy of ELA combined with DCB may be superior to that of DCB alone. For patients with FP-ISR <200 mm, DCB alone may achieve satisfactory efficacy, thus reducing the medical burden on patients and allowing for the selection of more appropriate treatment options for different types of lesions.

Purpose: Tier 1 of the International RIsk Stratification in EndoVascular Aneurysm Repair (IRIS-EVAR) project aimed to identify important risk factors for adverse events following endovascular aneurysm repair (EVAR).

Materials and methods: Initially, the steering committee proposed a number of risk factors for adverse events following EVAR. A Delphi consensus was performed as expert panelists were presented with risk factors and provided the opportunity to propose additional risk factors during the process. Experts in EVAR completed an online survey via 3 structured rounds. The first round opened in July 2022, and the third round closed in December 2022. Panelists rated risk factors using a 4-point Likert scale. Consensus was defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a statement in each round.

Results: Thirty-five panelists from 12 countries completed the 3 rounds of surveys. Of a total of 64 individual risk factors assessed by the panelists, 37 (58%) had consensus that they were important for adverse events following EVAR. Risk factors were stratified in 4 domains: 14 (38%) were related to preoperative anatomy, 3 (8%) related to the aortic device selection, 8 (22%) related to the procedure performance, and 12 (32%) related to postoperative surveillance. Factors with the highest consensus in each domain were as follows: proximal aortic neck length <15 mm (98% consensus), anatomy non-compliant with instructions for use (94% consensus), length of achieved proximal aortic neck post implantation <10 mm (98% consensus), and non-satisfactory seal at landing or overlapping zones/sac expansion/kink or stenosis (100% consensus each), respectively.

Conclusions: Clinically important risk factors for adverse events after EVAR were identified via expert consensus. These factors will be used to develop an expert consensus-informed risk stratification and surveillance strategies.Clinical impactThis is the first study to apply an in-depth Delphi methodology to achieve an expert consensus on risk factors for adverse events after endovascular aneurysm repair (EVAR). Important risk factors were stratified in 4 domains: preoperative anatomy (14 factors), aortic device (3 factors), EVAR procedure (8 factors), and postoperative surveillance (12 factors). This study will potentially influence future clinical practice by providing evidence informed by experts regarding predictors of adverse events following EVAR that can be taken into account during decision making and developing post-EVAR surveillance strategies. These findings will inform a risk stratification tool for everyday use by vascular surgeons.

Purpose: Although endovascular therapy (EVT) is considered a vital strategy for treating infrapopliteal lesions in chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT exceeds that after bypass surgery (BSX). The optimal approach for managing infrapopliteal lesion recurrence in patients with CLTI and unhealed ulcers remains uncertain. This study aimed to evaluate the clinical outcomes of repeat EVT and subsequent inframalleolar BSX for CLTI with infrapopliteal lesion recurrence.

Materials and methods: We conducted a retrospective analysis of 140 patients with CLTI (mean age, 70±10 years; male, 71.4%; diabetes mellitus, 73.6%; dialysis, 74.3%; Rutherford 5, 79.3%; and Rutherford 6, 20.7%) who had an unhealed wound due to the recurrence of infrapopliteal lesions between January 2015 and May 2020. We compared the clinical outcomes of 40 patients who underwent the subsequent inframalleolar BSX with those of 100 patients who underwent repeat EVT. The outcome measures were amputation-free survival (AFS) and wound healing rate. Propensity score matching analysis was conducted to minimize differences in baseline characteristics.

Results: Propensity score matching extracted 38 pairs (38 patients in the subsequent BSX group and 83 patients in the repeat EVT group). AFS was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). No baseline characteristics had any significant interaction effect on the association between repeat EVT, subsequent BSX, and failure of AFS.

Conclusion: This study using propensity score matching revealed that the clinical outcomes following repeat EVT were comparable with those following subsequent inframalleolar BSX, indicating that repeat EVT may be a viable treatment option for CLTI with infrapopliteal lesion recurrence.Clinical ImpactAlthough endovascular therapy (EVT) has expanded the treatment options for chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT is higher than that after bypass surgery (BSX). This retrospective study compared the clinical outcomes of repeat EVT with those of subsequent BSX for CLTI with infrapopliteal lesion recurrence. After propensity score matching, amputation-free survival (AFS) was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). There was no difference between the 2 revascularization strategies when treating infrapopliteal restenosis lesions.